Compositions for oral administration of zoledronic acid or related compounds for treating complex regional pain syndrome

Abstract

Oral dosage forms of osteoclast inhibitors, such as nitrogen-containing bisphosphonates, such as zoledronic acid in an acid or a salt form can be used to treat or alleviate pain or related conditions, such as complex regional pain syndrome.

What is claimed is: 
     
       1. A method of treating pain associated with complex regional pain syndrome, comprising orally administering zoledronic acid in an acid form or a salt form to a human being suffering from complex regional pain syndrome, wherein each time about 30 mg to about 100 mg of zoledronic acid in the salt form or the acid form, based upon the weight of the acid form, is administered at least twice approximately weekly until about 100 mg to about 320 mg of zoledronic acid in the salt or the acid form, based upon the weight of the acid form, have been administered to the human being, wherein the human being has suffered a traumatic event associated with the complex regional pain syndrome. 
     
     
       2. The method of  claim 1 , wherein about 50 mg of zoledronic acid in the salt form or the acid form, based upon the weight of the acid form, is administered to the human being approximately weekly. 
     
     
       3. The method of  claim 2 , wherein the zoledronic acid in the salt form or the acid form is administered at least 3 times. 
     
     
       4. The method of  claim 3 , wherein the zoledronic acid is administered in a disodium salt form. 
     
     
       5. The method of  claim 1 , wherein each orally administered dose contains about 50 mg to about 65 mg of the zoledronic acid in the disodium salt form. 
     
     
       6. The method of  claim 5 , wherein the zoledronic acid in the disodium salt form is administered 6 times. 
     
     
       7. The method of  claim 1 , wherein the pain is debilitating. 
     
     
       8. The method of  claim 1 , wherein, as a result of orally administering the zoledronic acid in the acid form or the salt form, the human being experiences a reduction in edema. 
     
     
       9. The method of  claim 1 , wherein, as a result of orally administering the zoledronic acid in an acid form or a salt form, an area affected by the complex regional pain syndrome experiences a reduction in temperature. 
     
     
       10. The method of  claim 1 , wherein the zoledronic acid in the acid form or the salt form is orally administered in a manner that results in a 24-hour sustained plasma level factor that is at least 1.5 times that of 4 mg of zoledronic acid administered intravenously. 
     
     
       11. The method of  claim 1 , wherein the zoledronic acid is orally administered in a manner that results in a 48-hour sustained plasma level factor that is at least five times that of 4 mg of zoledronic acid administered intravenously. 
     
     
       12. The method of  claim 1 , wherein the human being is not suffering from cancer or osteoporosis. 
     
     
       13. The method of  claim 1 , wherein the human being is not suffering from a solid tumor. 
     
     
       14. The method of  claim 1 , wherein the human being is not suffering from bone metastases. 
     
     
       15. The method of  claim 1 , wherein the human being is not suffering from a blood cancer. 
     
     
       16. The method of  claim 1 , wherein the human being is not suffering from a leukemia. 
     
     
       17. The method of  claim 1 , wherein the zoledronic acid is orally administered in a dosage form that, other than a sodium counter-ion to zoledronic acid, contains no agents which enhance the bioavailability of zoledronic acid. 
     
     
       18. The method of  claim 1 , wherein the zoledronic acid is orally administered in a dosage form that, other than a disodium salt of zoledronic acid, contains no agents which enhance the bioavailability of zoledronic acid. 
     
     
       19. The method of  claim 1 , wherein the zoledronic acid is orally administered in a dosage form that further comprises silicified microcrystalline cellulose, a crosslinked polyvinylpyrrolidone, a fumed silica, or magnesium stearate. 
     
     
       20. The method of  claim 1 , wherein the zoledronic acid in the acid form or the salt form is co-administered with steroid. 
     
     
       21. The method of  claim 1 , wherein the human being experiences a reduction in pain that lasts at least one month. 
     
     
       22. The method of  claim 1 , wherein the human being experiences a reduction in pain that lasts at least three months. 
     
     
       23. The method of  claim 1 , wherein the method reduces the use of a pain relief medication, other than the zoledronic acid, by the human being. 
     
     
       24. The method of  claim 1 , wherein the method reduces the use of a pain relief medication, other than the zoledronic acid, by the human being, about three months after orally administering the zoledronic acid. 
     
     
       25. The method of  claim 1 , wherein the method reduces the use of a pain relief medication, other than the zoledronic acid, by the human being, about one year after orally administering the zoledronic acid. 
     
     
       26. The method of  claim 1 , wherein the method reduces the use of a non-steroidal anti-inflammatory drug by the human being. 
     
     
       27. The method of  claim 1 , wherein the method reduces the use of a non-steroidal anti-inflammatory drug by the human being by at least about 50%. 
     
     
       28. The method of  claim 4 , wherein the zoledronic acid is administered in a dosage form containing at least 50% of the disodium salt form of zoledronic acid by weight. 
     
     
       29. The method of  claim 1 , wherein the zoledronic acid is orally administered in a solid dosage form having an enteric coating. 
     
     
       30. The method of  claim 1 , wherein the zoledronic acid is orally administered in a solid dosage form having a film coating.